Author: Catalina Diesner-Limban, Director, Clinical Trial Payments, EMEA, IQVIA Technologies
Managing clinic trial payments is a complex process that encompasses unique challenges specific to individual countries and regions. The use of software alone is not enough to ensure reliable, timely and equitable site payments. Deploying a successful global payment program demands a deep understanding of the differences between frameworks and locations, and a sustainable approach to resolving them. For sponsors and contract research organizations (CROs) operating in a multi-country environment, embracing this diversity is key to successfully implementing a payment solution.
Challenges in Global Clinic Trial Payments
Implementing payment solutions in EMEA, APAC and LATAM differs from the processes used in North America. This is not unexpected due to the diversity of the countries involved, but it does give rise to several challenges. The primary issues facing sponsors and CROs in these regions are:
1. Variable Local Tax Law
Tax regulations differ between regional conventions and country-specific regulations. Most are not set in stone and frequent changes in the laws occur. A volatile political situation could cause local laws to change overnight, impacting tax law, civil codes and internal practices such as invoice submission and payment timelines. Sponsors and CROs must keep pace with the amendments and adapt their processes to meet them.
Best Practices to Address this Challenge
Navigating and remaining compliant with regulations across multiple countries requires a well-established technology and knowledge network. Sponsors and CROs can benefit from using local tax specialists, particularly during the trial start-up phase, to establish appropriate contracting models and invoicing instructions compliant with local tax regulations.
2. Contractual Diversity
Extensive diversity exists in some locations regarding contract management. Individual countries’ laws dictate CTA templates. Sponsors, CROs and individual sites can insist on using their own contracting model. Local law and practices overwrite standard contract terms and agreements, giving rise to variations such as dispute terms and timelines for raising invoices.
Trial sites’ internal regulations demand flexibility. Complex contract language regarding the inclusion criteria of subjects during screening and randomization (SF ratio) can cause misunderstandings and site dissatisfaction. Differences may also exist between the local, regional or central contracting model and cash disbursement options such as local offices or the central bank.
Best Practices to Address this Challenge
Payment systems must remain flexible and agile enough to provide streamlined service, regardless of contract terms. Often, sponsors and CROs can make small changes in the contract language that result in considerable improvements in the payments process.
3. Cultural and Linguistic Diversity
Understanding local business practices and the history behind them is important. While a particular practice may be feasible in theory, it may not necessarily be widely adopted in a region or country. Managing these aspects of diversity across more than 90 countries and nearly 40 different languages require a well-versed team. Dealing with this level of diversity, sponsors of clinical trials must anticipate frequent changes and amplify their adaptability.
Issues such as domestic cooperation, wars and civil wars, changes in governmental structures, the fraud rate and currency controls also impact the disbursement situation. In addition to the differences in tax structures, regulatory environments, languages and time zones, some EU countries are less “business-friendly,” which requires adjustment by sponsors.
Best Practices to Address this Challenge
Sponsors and CROs must seek solutions tailored to organizational needs that mesh with established regional practices. They should actively listen to site teams and aim to speak the same language. They must be able to adapt quickly to changes, automate tasks created by local variances and design tailored solutions.
4. Historical Approaches to Payments
Sponsors and CROs often find clinical sites historically have several different groups involved in a payment process, even if they are not rooted in the payments department. The sites depend on clinical research associate (CRA)/clinical trial associate (CTA) involvement to manage payments.
Best Practices to Address this Challenge
Eliminating the administrative burden of invoicing and tracking payments from clinical site staff and CRAs requires sponsors to ensure all operations can be completed within the payments group. Implementing a gradual transition process to exclude the local clinical team from the payment process enables site staff to trust in the speed and responsiveness of the payments process. This approach frees the clinical team to focus on activities supporting the medical site team.
5. Complex Payment Scenarios
Many countries adopt complex payment frameworks, especially those in the regions mentioned above. These include having multiple payees accompanied by a variable distribution of payments. For example, a site could operate on a fixed percentage of budget split, a split between study team members’ payments, performance-based payments for work completed, self-billing or several other alternatives.
Best Practices to Address this Challenge
Sponsors and CROs must retain the flexibility to provide services in any payment model they encounter, however unusual it is. Stakeholders must implement a technological solution that includes features such as a streamlined workflow system and automated proforma invoicing notifications. A transparent, self-service payments portal and a subject accrual log help sites monitor payment activity, and site invoice recipients are notified in their preferred language when payments are released.
6. Communication Challenges
Due to language and cultural disparities, communication between sponsors, sites, and project teams is complex. Each additional country and language increase the number of stakeholders and the complexity exponentially. This amplifies the need for high-touch communications to enable sponsors and CROs to respond successfully to issues and inquiries. These variances in regional and country requirements create a dynamic environment for CROs aiming to provide tailored solutions in multiple locations and languages.
Best Practices to Address this Challenge
Each trial site needs a dedicated team to respond to queries in local languages. Automated welcome emails and step-by-step payment process instructions help bridge the gap. Proactive outreach anticipates common questions, while customized research drives responses for unique circumstances and supports effective communication.
Navigating a Dynamic Environment
Deploying a successful global program for paying clinical research sites is an achievable and worthwhile goal. However, it demands a deep understanding of the geographical differences in frameworks and motivations. It also requires a robust technological solution containing features aimed at streamlining the workflow and helping sites manage payments. Embracing diversity is critical for sponsors and CROs to implement best practices and effectively navigate their global payment operations.
